Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. This study is planned to start in late 2024 and conclude in late 2025.

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The Pharma Data

DECEMBER 9, 2020

The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days.

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The Pharma Data

DECEMBER 28, 2020

The primary objectives of the AMBITION trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. In this study, which is being conducted at 10 U.S.

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The Pharma Data

AUGUST 29, 2020

LNP023 also demonstrated a favorable safety and tolerability profile with no serious treatment-related infections or thromboembolic events. Following the cut-off date for the presented data, one participant, who had severe lymphopenia at study entry, discontinued treatment due to a serious adverse event (AE) of lymphoproliferative disorder.

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The Pharma Data

OCTOBER 25, 2020

In addition, this indication offers synergy with the commercial infrastructure being developed to support our first New Drug Application.”. is a clinical stage biopharmaceutical company focused on drug development that utilizes artificial intelligence to identify improved therapies in neuroscience and immuno-oncology.

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Agency IQ

DECEMBER 11, 2023

So far, the key takeaway was that both industry and regulators are still identifying best practices on setting enrollment targets in their research plans. Per Roy, “it’s basically a work in progress,” as the plans are being developed and translated into practice, and the company is still receiving iterative feedback from the FDA.

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Agency IQ

FEBRUARY 23, 2024

Workshop addresses oncology dose optimization across full span of development In a series of broad-ranging, frank discussions, attendees at a joint FDA-American Association of Cancer Research (AACR) workshop worked through opportunities and challenges for dose optimization across the span of cancer drug development activities.

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